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Home Aviceda Therapeutics Announces Positive Phase 2/3 Clinical Results for AVD-104 in Geographic Atrophy Secondary to Age-Related Macular Degeneration

Aviceda Therapeutics Announces Positive Phase 2/3 Clinical Results for AVD-104 in Geographic Atrophy Secondary to Age-Related Macular Degeneration

Jan 17, 2024 08:05 CST Updated 08:05
Aviceda Therapeutics

Pharmaceutical R&D Manufacturer

▎Edited by the WuXi AppTec content team

Aviceda Therapeutics today announced positive topline data from the first part of the SIGLEC Phase 2/3 clinical trial for AVD-104, an investigational therapy for geographic atrophy (GA) caused by age-related macular degeneration (AMD).The trial results showed positive safety and efficacy outcomes observed three months after a single dose of AVD-104 treatment.AMD is one of the leading causes of blindness in people over 50.

All participants in the first part of the trial were able to tolerate a single dose of AVD-104 treatment at 3 months. Notably, no serious adverse reactions related to the drug were reported.Compared with historical standard-of-care outcomes, there was a significant reduction in GA lesion growth at three months. Patients also experienced significant improvement in best-corrected visual acuity (BCVA) following a single injection of AVD-104, maintaining these benefits over three months.

AVD-104 is a nano-immunomodulatory therapy developed based on the company's HALOS nanotechnology platform. It is currently under investigation for the treatment of GA caused by AMD and diabetic macular edema.This glycoprotein-modified nanoparticle for intravitreal injection works through a dual mechanism: 1) directly inhibiting harmful phagocytic/inflammatory macrophages and repolarizing activated microglia to a neuroprotective state, and 2) suppressing the complement cascade signaling pathway.

The second part of the SIGLEC trial is a multicenter, randomized, double-blind study with an active control, designed to further evaluate the efficacy and safety of AVD-104 compared to the active control drug (avacincaptad pegol) in treating GA caused by AMD. The trial will enroll approximately 300 patients, with a treatment period of 12 months, and patients will have the opportunity to receive an additional 12 months of treatment in the study. The primary endpoint is to assess the difference in the growth rate of GA areas between the treatment group and the active control group at 12 months.

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